MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for PLATE-BENDING PRESS 329.30 manufactured by Synthes (usa).
[46581959]
Device was used for treatment, not diagnosis. Patient information is not available for reporting. Date of event: unknown. (b)(4) lot number unknown. Device is an instrument and is not implanted/explanted. A service and repair history record review will be requested once the lot/serial number of the device is identified. The subject device has been received and is currently in the evaluation process. Device manufacture date: unknown. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[46581960]
It was reported that a plate bending press was found missing the lower anvil during an unknown surgical procedure on an unknown date. Reportedly, the surgeon requested the plate bending device to bend an unspecified, non-synthes device. When the plate bending press was unwrapped the surgeon noted that the lower anvil was missing. It was suspected to be discarded or misplaced. The surgeon did not have a back-up device but was able to successfully complete the surgery as planned without the complained device. There was reportedly no delay to the surgery and no impact on the patient. The patient's postoperative status was reportedly fine. This is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[46695586]
No service history review can be performed because the lot/serial number is unknown and cannot be traced. The manufacture date is unknown. The service history review is unconfirmed. A service and repair evaluation was completed: the customer reported the lower anvil missing. The repair technician reported the lower anvil adjustment screw was worn, and the lower anvil was missing. Missing parts is the reason for repair. The cause of the issue is unknown. The following parts were replaced: lower anvil adjustment screw, lower anvil. The item was repaired per the inspection sheet, passed synthes final inspection and will be returned to the customer upon completion of the service and repair process. The evaluation was confirmed. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2520274-2016-12709 |
| MDR Report Key | 5660440 |
| Date Received | 2016-05-17 |
| Date of Report | 2016-04-29 |
| Date Mfgr Received | 2016-05-19 |
| Date Added to Maude | 2016-05-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TERRY CALLAHAN |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 6107195000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PLATE-BENDING PRESS |
| Generic Name | INSTRUMENT, BENDING OR CONTOURING |
| Product Code | HXP |
| Date Received | 2016-05-17 |
| Returned To Mfg | 2016-05-17 |
| Catalog Number | 329.30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES (USA) |
| Manufacturer Address | 1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-17 |